Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as MK0524B
niacin laropiprant simvastatin · 2 trials · 3 indications
Plasma Area Under the Curve of simvastatin acid, the active metabolite of simvastatin
Peak Plasma Concentration (Cmax) for Simvastatin Acid, the active metabolite of simvastatin
Plasma Area Under the Curve of simvastatin
Plasma Area Under the Curve of Laropiprant
Peak Plasma Concentration (Cmax) for Nicotinuric Acid, one of the active metabolites of Niacin
| Arm | Type | Description |
|---|---|---|
| MK0524B then Simvastatin + MK0524A | EXPERIMENTAL | Period 1: 1 tablet of MK0524B (ER niacin 900 mg/ laropiprant 20 mg/ simvastatin 20 mg). Period 2: 1 tablet of simvastatin 20 mg (Zocor™) and 1 tablet of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) as separate tablets. |
| Simvastatin + MK0524A then MK0524B | EXPERIMENTAL | Period 1: 1 tablet of simvastatin 20 mg (Zocor™) and 1 tablet of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) as separate tablets. Period 2: 1 tablet of MK0524B (ER niacin 900 mg/ laropiprant 20 mg/ simvastatin 20 mg). |
| Name | Type | Description |
|---|---|---|
| niacin (+) laropiprant (+) simvastatin | DRUG | Duration of Treatment 12 Weeks |
| Comparator: niacin (+) laropiprant | DRUG | Duration of Treatment 12 Weeks |
| Comparator: simvastatin | DRUG | Duration of Treatment 12 Weeks |
| MK0524B (ER niacin (+) laropiprant (+) simvastatin) | DRUG | Single dose of MK0524B (ER niacin 900 mg/ laropiprant 20 mg/ simvastatin 20 mg) in one of two treatment periods. |
| MK0524A (ER niacin + laropiprant) | DRUG | Single dose of MK0524A (ER niacin 1000 mg/ laropiprant 20 mg) in one of two treatment periods. |
| Simvastatin | DRUG | Single dose simvastatin (Zocor™) 20 mg in one of two treatment periods. |
Inclusion Criteria: * Patients 18 to 85 years of age with primary hypercholesterolemia or mixed hyperlipidemia * LDL-C between 130 and 190 mg/L (Category I) and 130 and 160 mg/L (Category II) and triglycerides \</= 350 mg/dL. Exclusion Criteria: * A condition which, in the opinion of the investig...
Niacin laropiprant simvastatin is an investigational oral small molecule combination therapy developed by Merck & Company, Inc. (MRK) for primary hypercholesterolemia. It combines three active components into a single fixed-dose product intended to lower cholesterol. The combination was studied in a Phase 3 clinical program and is not described as approved.
Niacin laropiprant simvastatin was developed for the treatment of primary hypercholesterolemia, a condition of elevated cholesterol in the blood. The Phase 3 trial also enrolled patients with mixed hyperlipidemia. It is a cardiovascular-directed lipid-modifying combination therapy rather than a treatment for an acute condition.
Merck & Company, Inc., which trades under the ticker MRK, is the developer of niacin laropiprant simvastatin. Merck sponsored the Phase 3 lipid efficacy study of the combination. No other developer or partner is associated with the asset in the available record.
Niacin laropiprant simvastatin reached Phase 3 clinical development. One Phase 3 trial has been completed, and no trials are currently active. The program is therefore an investigational combination that has finished its recorded late-stage study rather than a marketed product.
Niacin laropiprant simvastatin was studied in the Phase 3 Lipid Efficacy Study (0524B-022), registered as NCT00269217. That trial is completed and enrolled 1,400 participants aged 18 years and older of all sexes. It was randomized and double blind, with an uncontrolled design, and enrolled patients with primary hypercholesterolemia and mixed hyperlipidemia.